Some congressional leaders, including Anand Sharma, Shashi Tharoor and Jairam Ramesh, expressed serious concerns on Sunday about granting Covaxin approval for restricted use, saying it is “premature” and may prove dangerous.
COVAXIN’s approval is ‘Supervised Approval’ with strict monitoring and continuous review. This approval ensures that India has a… https://t.co/GMg6eCHQqi
– Dr. Harsh Vardhan (@drharshvardhan) 1609690151000
In response to them, Vardhan said that it is “a shame that someone politicizes such a critical issue.”
Tagging Tharoor, Ramesh and Samajwadi Party Leader Akhilesh Yadav, the health minister said in a tweet: “… do not try to discredit the well-established and science-backed protocols that are followed to approve # Covid19 vaccines. . yourselves!”
Vardhan said: “COVAXIN is more likely to work against newer variants such as variant N501Y (UK variant) and any other that may arise due to antigenic drift as it contains immunogens (epitopes) from genes other than those of Spike protein. ”
For those who spread rumors, let it be known that USA for COVAXIN is conditional differently, in clinical trial mode … https://t.co/2mK68l3D3Z
– Dr. Harsh Vardhan (@drharshvardhan) 1609690147000
SP President Yadav said that the Covid-19 vaccination program is a “sensitive process” and that the government should not treat it as a “cosmetic” event, as it is a matter of lives.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR).
ICMR Director General Balram Bhargava also said that Covaxin is based on an inactivated whole virus, which has the potential to target mutated coronavirus strains, including the UK variant, which was a major reason for giving it a conditional nod.
However, he said that so far there are no clear data on the efficacy of the vaccine.
The data generated so far demonstrate a strong immune response (both antibody and T-cell) and viral neutralization in vitro. The ongoing clinical trial is the largest trial involving 25,800 subjects, with 23,000 volunteers already enrolled, including subjects with comorbid conditions, and the vaccine has shown safety to date, Bhargava said.
To further allay apprehensions around the Bharat Biotech vaccine, Vardhan said there were no seroconversions in those who received vaccines in the Phase II and Phase I clinical trials of Covaxin.
Seroconversion is the transition from the point of viral infection to the moment when antibodies to the virus are present in the blood.
“Our experience with inactivated vaccines that do not have serious adverse effects was also seen in Phase II conducted among 380 BBV152 study participants at a follow-up of 21,280 person-days. No serious adverse effects were observed. Only 7% of people who received a 6-microgram dose had mild symptoms, “Vardhan said in another tweet.
“Data from the phase I and II clinical trials of COVAXIN reveal that it not only produces neutralizing antibodies in all participants, but also sensitizes CD4 T cells that impart a durable immune response,” Vardhan tweeted.
He said that globally approved vaccines based on genes encoding spike proteins have a protective efficacy of more than 90 percent.
“However, COVAXIN based on whole inactivated virus has other antigenic epitopes in addition to the spike protein. Therefore, it is likely to have a similar protective efficacy reported for others,” he said.
India’s drug regulator approved Oxford’s Covid-19 Covishield vaccine, made by the Serum Institute, on Sunday and locally developed Bharat Biotech’s Covaxin for emergency restricted use in the country, paving the way for a massive inoculation campaign. .
The Comptroller General of Drugs of India (DCGI) granted approval based on the recommendations of a Covid-19 Subject Matter Expert Committee (SEC) of the Central Drug Standards Control Organization (CDSCO).
.
